Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Will FDA's One-Day Inspection Pilot Stand The Test Of Time?

FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

GUEST COLUMNISTS

Closing The MES Value Gap: Why Technology Isn't The Problem
Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.
Why Isolators Do Not Automatically Ensure Annex 1 Compliance
Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is not the technology itself, but how it is applied.
Why Are Life Science Companies So Poorly Prepared For RIM's Future?
Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.
CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?
Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.
April 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem
As the regulatory landscape continues to evolve, cell and gene therapy companies must plan post-approval change programs with regulatory monitoring built in from the start.
Why Your MES RFP Is Failing Before It Starts
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.
Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24
FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.

PHARMA OUTSOURCING WHITE PAPERS

Driving Operational Excellence Using Machine Learning
Explore how advanced machine learning and data analytics are revolutionizing biopharmaceutical manufacturing and driving operational excellence.

Late‑Stage Progress In Excipients For Precision Nanomedicine
View late‑stage development and GMP manufacturing of novel excipients for nanomedicines, emphasizing regulatory rigor, process optimization, analytics, and scale‑up for lipid‑based delivery systems.
The Evolution Of Antibody-Drug Manufacturing
Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.
Patented Process For Intermediates Useful For Etrasimod Arginine
Explore how rethinking the synthetic strategy for Etrasimod can overcome the limitations of legacy routes, enabling more efficient chirality control, improved scalability, and more practical industrial API production.
Digital Innovation In Pharmacovigilance
Explore how AI can transform your pharmacovigilance efforts and enhance patient safety by leveraging the insights and decision framework outlined here.
Spray Dry Biologics For Oral Dosage Forms
Spray drying enables stable oral delivery of biologics by creating protective dry powders, improving bioavailability, stability, and targeted release compared with traditional formulation methods.